1. Field of the Invention
The present invention relates to a disposable dispensing apparatus and method for providing nutritional and/or therapeutic agents to humans and other animals. In particular, the invention relates to a shelf-stable blister pack having a plurality of recesses designed to conveniently supply a dosing regimen requiring administration of storage-incompatible or unevenly dosed components.
2. Description of the Related Art
Physiological requirements vary from individual to individual and even within an individual during the course of a lifetime. Further, various conditions may effect physiological requirements. For example, pregnant, lactating and menopausal women may have enhanced needs for certain nutrients, therapeutic agents or treatments and reduced needs, or even tolerance, for other nutrients, therapeutic agents or treatments.
Meeting the specific physiological requirements of humans and other animals may require the use of a complex daily therapeutic regimen requiring administration of various biologically-active substances simultaneously or at different times during the day. Moreover, the complex daily therapeutic regimen may require simultaneous administration of biologically-active substances which may be storage-incompatible. Storage-incompatibility exists between two or more substances when the substances may not be formulated together in a single dosage unit or stored together in direct contact because the substances will interact in a negative manner. Storage-incompatibility also exists between two or more substances that cannot be formulated together in a single dosage unit because the sum total of the dosage amounts of the substances would result in a single dosage unit which is difficult to swallow or at least not optimal for swallowing. Storage-incompatibility also exists between two or more substances wherein at least one substance is a prescription substance and at least one substance is a non-prescription substance.
In addition the problem of simultaneous administration of storage-incompatible substances, complex daily therapeutic regimens also present the problem of poor patient compliance. In fact, according to medical literature, approximately 30% to 50% of all patients fail to comply with their physician""s prescriptions. See Libow et al., The Core of Geriatric Medicine: A Guide for Student and Practitioners, 107 (1981). Interviews conducted with 178 elderly outpatients revealed that 59% are making errors in their medications and about 25% of the group as a whole averaged as many as 2.3 potentially serious errors per patient. See Schwartz et al., xe2x80x9cMedication Errors Made by Elderly, Chronically Ill Patientsxe2x80x9d, American Journal of Public Health, 52:2018-29 (1962).
Further, a study examining non-compliance in patients recently discharged from an acute care facility found that 50% of the patients deviated from the prescribed regime. See Parkin et al., xe2x80x9cDeviation from Prescribed Drug Treatment After Discharge from Hospitalxe2x80x9d, British Medical Journal, 2:686 (1976). Moreover, there is evidence that medication errors are an important factor in producing illness. See Seidl et al., xe2x80x9cStudies on the Epidemiology of Adverse Drug Reactionsxe2x80x9d, The Bulletin of Hopkins Hospital, 119:299-315,1966.
There are a broad range of factors which play a role in poor patient compliance, including complexity of regimen, poor patient motivation, lack of sufficient knowledge on the part of the patient, memory loss and other cognitive dysfunctions, as well as attenuation of the special senses.
Disposable pharmaceutical containers for dispensing medicaments which are used to improve patient compliance have been previously disclosed. One type of pharmaceutical dispensing package arranges medicaments separately within individual recesses upon a planar card, forming a blister package. An example of such a package can be found in Knudsen, U.S. Pat. No. 4,295,567, which discloses a pharmaceutical dispensing container which holds two dosage units which are symptomatic treatment for respiratory tract disorders. The first of these dosage units being indicated for day-time administration and therefore being non-sedating. The second of these dosage units being indicated for night-time administration and therefore being sedating. Means of indication include dosage units being in register with a time chart and a distinguishing visible feature of the dosage units.
Thompson et al., U.S. Pat. No. 5,358,118, describe a stepped-edge blister pack for containing and dispensing units of doses of medication such as capsules, tablets, caplets or fast-dissolving dosage forms. The invention is comprised of a base sheet and a substantially planar lidding sheet. The base sheet has a plurality of blister compartments and a plurality of steps along its edges, one step being adjacent to each blister compartment. The substantially planar lidding sheet is peelably sealed to the base sheet except at extended edge regions, thus forming edge peel tabs. These edge peel tabs coincide with the steps along the edge of the base sheet, thus providing a series of finger accesses and thereby easing the process of opening each blister compartment. The lidding sheet is scored with lines of weakening, so that each blister compartment is removable from the blister package.
Sowden, U.S. Pat. No. 5,325,968, describes a package for holding tablets, which provides for limited entry into the package that is designed to be child proof. The user must complete a number of sequential steps in order to access the dosage. First, the user grips a trapezoidal section of an access tab to expose a finger depression. Next, the user grips a cover overlying the depression, which further extends over the dosage. Finally, the user pulls back this cover to reveal the dosage form.
Urheim, U.S. Pat. No. 4,958,736, describes a package for oral contraceptive tablets. The package contains four rows of seven tablets per row. Three adjacent rows contain active contraceptive tablets, while he fourth row contains placebo tablets. A line of severability is provided between the row placebo tablets and an adjacent row of active tablets, thereby enabling dispensing 21-day and 28-day oral contraceptive formulations using a single package.
Roulin et al., U.S. Pat. No. 5,695,063, describe a blister pack for pharmaceuticals containing a base with a plurality of recesses which are surrounded by a shoulder. A lid foil is attached to the shoulders. Removable contents such as a tablet, capsules, or ampoules reside in each of the recesses and may be removed therefrom by pressing the recess in question and penetrating the lid foil or by removing the lid foil over the recess. The blister pack features a movable lid or a clamping element which covers at least one recess, and the clamping element is arranged in such a manner that it can be slid over the lid foil, and the clamping element closes off again at least one recess where the lid foil has been penetrated or peeled back, or close again at least one lid which on filling was left untitled and without a lid.
D""Amico et al., U.S. Pat. No. 5,788,974, describe a pharmaceutical dispensing container which holds multiple dosage units for aiding in the compliance in the eradication/treatment of Helicobacter pylori and subsequent/related gastric maladies on relation to said bacterial infection using a repetitive dosage regimen for a treatment period of sufficient duration to mitigate said bacterial infection formatted in such a way to gain ease of compliance resulting in improved outcome of treatment. Dosage units may be antibiotic, anti-microbial, or symptomatic relief agents in any combination.
Bartell et al., U.S. Pat. No. 4,889,236, describe a rigid, tripartite, credit card-style blister pack medication package, which is particularly useful for dispensing medications which must be taken on a calendar day schedule. The package is of discrete design and may be conveniently carried in a purse or billfold.
Roulin et al., U.S. Pat. No. 5,624,036, describe a blister pack without additional packaging for pharmaceuticals, having a base with a plurality of recesses that are surrounded by a shoulder and a lid foil attached to the shoulder, where removable contents are accommodated in the recesses and can be removed therefrom by pressing in the recess in question and penetrating the lid foil or by removing the lid foil over the recess and having an accompanying leaflet. The accompanying leaflet represents part of the blister pack and is situated within the confines of the blister pack, for example in a compartment in the base or in a gripping facility on one side of the blister pack.
Bitner, U.S. Pat. No. 5,310,060, describes a novel tamper-evident, child-resistant blister package for medicaments and non-medicaments which is difficult to open by young children and impaired adults. Because the blister package has pull tabs which are designed to be pulled away from, rather than towards, article receiving pockets which may be present in the blister package other than the article receiving pocket being accessed, a young child or user of the blister package can only access one article receiving pocket at a time, whether deliberately or inadvertently. The blister package of the invention is an attractive and inexpensive package for the merchandising of pharmaceutical and other products which is constructed in a manner which facilitates mass production.
This type of pharmaceutical dispensing package wherein medicaments are arranged separately within individual recesses upon a planar card, forming a blister package, may further be inserted into a container designed to protect and/or otherwise further precipitate dispensing of the medication is also known in the art. An example of such a package can be found in Leonard et al., U.S. Pat. No. 4,376,849, which describe a method and apparatus to store and aid in dispensing of calendar-oriented drugs. The apparatus is comprised of a carrier containing a plurality of pill-containing enclosures, which are arranged in rows. Numerical and/or alphanumerical indicia are associated with the enclosures so that each enclosure is associated with only one day in a calendar month. One or more additional enclosures in different rows may also be associated with the same calendar date. Corresponding indicia on the reverse side of the carrier aid in the determination of which enclosure(s) to open. The package also provides a visual indication of calendar days for which pills have not been used by the patient and in this way provides patient compliance information to the physician prescribing such drugs. This dispensing apparatus is particularly suited to the administration of calendar-oriented prescription drugs for the treatment of menopausal symptoms.
Allendorf et al., U.S. Pat. No. 5,265,728, describe an arrangement for retaining blister pack tablets, which comprises a container with at least a front cover and a rear cover with a blister pack sandwiched there between and visible through a window in the front cover. The blister pack includes indicia thereon indicating the order in which the tablets should be taken and the container includes a pointer identifying the first tablet in the array of tablets to be consumed. Preferably, the container includes a daily calendar in the form of a loop or cylinder which is movable with respect to the container so that a desired starting say can be selected by the user or prescriber. Preferably, the loop or cylinder is lockable at its selected position. In accordance with two embodiments of the invention, front and rear lids are pivoted to the front and rear covers, respectively, to conceal the blister pack until it is necessary to take a tablet.
Kelly, U.S. Pat. No. 4,817,819, describes a tablet container having a cover and sliding tray, which is used for dispensing birth control tablets for either a twenty-one day or twenty-eight day cycle. Normally, the tray does not slide completely out of the cover and is stabilized with respect thereto when open. The case resembles a cosmetic compact and is reusable in the once birth control tablets contained in the blister pack are used up, a new blister pack may easily be inserted.
Varon, U.S. Pat. No. 5,377,841, describes a package for sleep therapy including a box having cards with doses in the form of tablets or capsules thereon, some of which are sleep inducing medicine and some of which are placebos, and an audiogenic recording for inducing sleep.
Batchelor, U.S. Pat. No. 4,889,238, describes a medicament package for improving compliance with a therapeutic regimen. The therapeutic regimen involves a plurality of medications administered to a patient in a prescribed sequence and in accordance with specific intervals. The package includes a multiplicity of blister cards of generally uniform planar dimensions. The blister cards carry the medicaments in sequential order on the individual cards and from card to card. The blister cards being placed in a stacked array with the principle dimensions thereof oriented generally horizontally and arranged in order of use with the first to be used topmost. Also included is a base which houses the stack of blister cards. The base permits direct and unobstructed access to the uppermost blister card and limited access only to the edges of the blister cards. A lid is adapted to cover the base and a movable to an open position allowing access to the uppermost blister card. Each blister card generally contain indicia denoting the order and sequence when the contents of a particular blister cavity are to be consumed.
Hartman et al., U.S. Pat. No. 3,397,671, disclose a reminder-dispenser for pills and the like which includes a holder, a carrier to be held be the holder, a plurality of individually openable pill pockets on the carrier and indicia means associated with the holder for selective location relative to the carrier indicating the period of consumption of pills in respective pockets.
Romick, U.S. Pat. No. 5,109,984, describes a reusable, plastic medication dispensing containers for dispensing medication for a blister pack. The container includes a top, bottom and retaining frame that are molded from a one-piece plastic and hingeably connected one to the other.
Pharmaceutical dispensing packages wherein medicaments are arranged separately within individual recesses of a nondisposable apparatus are also known in the art. An example of such a package can be found in Denney, U.S. Pat. No. 4,749,085, which describes a rectangular, open-top shallow tray with enclosing side walls and has markings designating each day of the week equally spaced across the top. A set of individual compartments or pill boxes for each day of the week resting in the tray line with each of the designated days of the week and frictionally and removably held in place in the tray so that each of the set of pill boxes can be separately and individually removed from the tray whereby the user can conveniently carry prescribed medication for a given day separate from the other days of the week.
Martin, U.S. Pat. No. 4,473,156, describes an apparatus for accurately selecting, storing, and dispensing multiple varieties of pills at preselected time intervals such as morning, noon, evening and night, which also includes a separate pill container for each unique variety of pill to be dispensed. Each pill container is identified by a distinctive color or colors to indicate the time interval(s) during which the pills in it are to be dispensed. For example, each recess in the morning could be identified by the color red; at noon, at least yellow; in the evening, at least blue; and at night, at least black. Any particular container will, therefore, be identified by at least one and not more than four colors. A pill tray includes a plurality of pill holding compartments arranged in columns identified with each of the days of the week in a row, each row representing the time intervals, such as morning, noon, evening and night. Each pill holding compartment in the row representing morning is red, the row representing noon is yellow, the evening row is blue and the night row is black. The tray is loaded by putting one pill from each container in each of the compartments colored the same as one of the colors identifying that container. Sliding panels are provided as covers for each of the columns, and the patient can access the proper medication by uncovering the appropriate compartment at the appropriate time interval.
Will, U.S. Pat. No. 4,593,819, describes a rectangular tray configuration having an array of open-topped compartments, which serves to hold a supply of medication arranged day by day and by time of taking. Associated with the tray is a support base having provision for storage of medication containers. A case may be provided for the tray and includes a cover to permit the tray to be carried without danger of the pills moving from the individual compartments.
Cappuccilli, U.S. Pat. No. 4,039,080, describes a tray having individual compartments for holding pills, capsules, or similar solid medication, each compartment being rectangular in plan view and arranged in a rectangular format or seven columns and a plurality of rows. The tray may be load with a weeks worth of medication for an individual patient with indicia adjacent to each column indicating the day of the week, and indicia adjacent to each row indicating the time of day each compartment is to be taken. A lid or cover cooperates with the wall means defining the individual compartments to mutually isolate the compartments when in the closed position. The inner surfaces of the compartments are preferably rounded in at least one plane to facilitate ease of tablet removal.
The above discussed holders, dispensers and pharmaceutical packages are deficient in several respects. Significantly, none of the above references present a convenient, simple and effective way of facilitating the simultaneous administration of storage-incompatible substances, particularly when said substances are taken as part of a complex sequential daily therapeutic regimen. Further, none of the above references specifically addresses a way to facilitate simultaneous administration of prescription and non-prescription substances as part of a complex regimen. Moreover, none of the above references addresses the issue of optimizing therapeutic support for humans and other animals. Therefore, there remains a need for a simple, inexpensive and convenient means for providing optimal therapeutic support for humans and other animals, and in particular for providing optimal support for humans and other animals having special therapeutic needs.
The present inventive subject matter is directed to a storage stable, disposable dispensing apparatus and method which provides optimal therapeutic support while overcoming the deficiencies of currently available pharmaceutical packages in a simple, effective, convenient and cost-efficient manner.
One embodiment of the present inventive subject matter is a storage stable, disposable dispensing apparatus for providing optimal therapeutic support to an animal by increasing compliance with a complex dosing regimen, which could include a prescription substance and a nonprescription substance during one dosing interval and facilitating simultaneous administration of storage-incompatible substances, said apparatus comprising: a blister pack having a plurality of predetermined areas, each of said predetermined areas defining a first recess and a second recess; a first dosage unit occupying the first recess, said first dosage unit comprising a first biologically-active substance; a second dosage unit occupying the second recess, said second dosage unit comprising a second biologically-active substance; a day indicia could be provided on said blister pack, said day indicia corresponding to each of said predetermined areas to increase patient compliance with said complex dosing regimen by indicating which day the dosage units are to be administered; wherein the complex dosing regimen requires simultaneous administration of said first and second biologically-active substances; said first biologically-active substance being storage-incompatible with said second biologically-active substance; and wherein said first recess and said second recess provide shelf stability by independently isolating in close proximity said first dosage unit and said second dosage unit to prevent interaction between the first and second biologically-active substances while facilitating simultaneous administration of said substances.
Another embodiment of the present inventive subject matter relates to a storage stable, disposable dispensing apparatus for increasing patient compliance with taking at least one prescription therapeutic substance through proximity and conjoint accessibility with at least one nonprescription substance; said apparatus comprising a storage stable blister pack having at least one row of a plurality of predetermined areas, each area defining at least one recess; a first dosage unit occupying at least one recess of at least one of said predetermined areas, said first dosage unit containing a nonprescription substance; a second dosage unit occupying at least one recess of at least one of said predetermined areas, said second dosage unit containing a prescription therapeutic substance, said second dosage unit arrayed with said first dosage unit on said blister pack adjacent to said second dosage unit; a day indicia provided on said blister pack, said day indicia corresponding to at least one of said predetermined areas; and wherein each of said predetermined areas has a seal that is independently accessible, removable or breakable.
An alternative embodiment of the present inventive subject matter is a storage stable, disposable dispensing apparatus for increasing patient compliance with taking at least one prescription therapeutic substance through proximity and conjoint accessibility with at least one nonprescription substance, said apparatus comprising a storage stable blister pack having at least one row of a plurality of predetermined areas, each area defining at least one recess; a first dosage unit occupying at least one recess of at least one of said predetermined areas, said first dosage unit containing a nonprescription substance; a second dosage unit occupying at least one recess of at least one of said predetermined areas, said second dosage unit containing a prescription therapeutic substance, said second dosage unit arrayed with said first dosage unit on said blister pack adjacent to said second dosage unit; a day indicia provided on said blister pack, said day indicia corresponding to at least one of said predetermined areas; and wherein said row of a plurality of predetermined areas has a seal that is independently accessible, removable or breakable.
Yet another embodiment of the present inventive subject matter is a storage stable, disposable dispensing apparatus for increasing patient compliance with taking at least one prescription therapeutic substance through proximity and conjoint accessibility with at least one nonprescription substance, said apparatus comprising a storage stable blister pack having at least one row of a plurality of predetermined areas, each area defining at least two recesses; a first dosage unit occupying a first recess of a first predetermined area and containing a nonprescription substance; a second dosage unit occupying a second recess of said first predetermined area and containing a prescription therapeutic substance, said second dosage unit arrayed with said first dosage unit on said blister pack adjacent to said second dosage unit; a day indicia provided on said blister pack, said day indicia corresponding to at least one of said predetermined areas; and wherein each of said predetermined areas has a seal that is independently accessible, removable or breakable.
A further embodiment of the present inventive subject matter is a storage stable, disposable dispensing apparatus for increasing patient compliance with a daily therapeutic regimen through proximity and conjoint accessibility with a multiplicity of therapeutic components which are to be administered concurrently, which comprises a blister pack having at least one row of a plurality of predetermined areas, each area defining at least two recesses; a first dosage unit occupying a first recess of a first predetermined area and containing a first therapeutic substance; a second dosage unit occupying a second recess of said first predetermined area and containing a second therapeutic substance; said second dosage unit arrayed with said first dosage unit on said blister pack adjacent to said second dosage unit; a day indicia provided on said blister pack, said day indicia corresponding to at least one of said predetermined areas; and wherein each of said predetermined areas has a seal that is independently accessible, removable or breakable.
A still further embodiment of the present inventive subject matter is a storage stable, disposable dispensing apparatus for increasing patient compliance with a daily therapeutic regimen through proximity and conjoint accessibility with a multiplicity of therapeutic components which are to be administered concurrently, which comprises: a storage stable blister pack having at least one row of a plurality of predetermined areas, each area defining at least two recesses; a first dosage unit occupying a first recess of a first predetermined area and containing a first therapeutic substance; a second dosage unit occupying a second recess of said first predetermined area and containing a second therapeutic substance; said second dosage unit arrayed with said first dosage unit on said blister pack adjacent to said second dosage unit; a day indicia provided on said blister pack, said day indicia corresponding to at least one of said predetermined areas; and wherein each of said predetermined areas has a seal that is independently accessible, removable or breakable.
An even further embodiment of the present inventive subject matter is a storage stable, disposable dispensing apparatus for increasing patient compliance with taking at least one prescription substance through proximity and conjoint accessibility with at least one nonprescription substance, said apparatus comprising a storage stable blister pack having at least one row of a plurality of predetermined areas, each area defining at least one recess; a first dosage unit occupying at least one recess of at least one of said predetermined areas, said first dosage unit containing a prescription substance may be a hormone replacement agent, a contraceptive agent, an osteoporotic agent, a chemotherapeutic agent, an anti-infective agent, an analgesic, a steroid, an appetite suppressant, a weight loss agent, a tobacco antagonist, an cholesterol reducer and combinations thereof; a second dosage unit occupying at least one recess of at least one of said predetermined areas, said second dosage unit containing a prescription therapeutic substance, said second dosage unit arrayed with said first dosage unit on said blister pack adjacent to said second dosage unit; a day indicia provided on said blister pack, said day indicia corresponding to at least one of said predetermined areas; and wherein each of said predetermined areas has a seal that is independently accessible, removable or breakable.
Another embodiment of the present inventive subject matter is a disposable dispensing apparatus for providing optimal therapeutic support to an animal by increasing compliance with a complex dosing regimen and facilitating administration of uneven doses of a biologically-active substance, said apparatus comprising: a blister pack having at least two rows of a plurality of predetermined areas; a first row of predetermined areas, each of the predetermined areas defining a first recess adapted to receive a first dosage unit, said first row of predetermined areas having a first time indicia; a second row of predetermined areas, each of the predetermined areas defining a first recess adapted to receive a second dosage unit, said second row of predetermined areas having a second time indicia; and wherein the first dosage unit has a greater or lesser amount by weight of the biologically active than the second dosage unit.
Yet another embodiment of the present inventive subject matter is a disposable dispensing apparatus for providing optimal therapeutic support to an animal by increasing compliance with a complex dosing regimen and facilitating administration of uneven doses of at least one biologically-active substance, said apparatus comprising: a blister pack having at least two rows of a plurality of predetermined areas; a first row of predetermined areas, each of the predetermined areas defining a first recess adapted to receive a first dosage unit, said first row of predetermined areas having a first time indicia; a second row of predetermined areas, each of the predetermined areas defining a first recess adapted to receive a second dosage unit, said second row of predetermined areas having a second time indicia; and wherein the first dosage unit is larger by volume than, smaller by volume than, or a different shape from the second dosage unit.
Another embodiment of the present inventive subject matter is a method for providing optimal therapeutic support to an animal by increasing compliance with a complex dosing regimen and facilitating simultaneous administration of storage-incompatible substances, which comprises: providing a blister pack having a plurality of predetermined areas, each of said predetermined areas defining a first recess and a second recess; providing a first dosage unit occupying the first recess, said first dosage unit comprising a first biologically-active substance; providing a second dosage unit occupying the second recess, said second dosage unit comprising a second biologically-active substance; providing day indicia on said blister pack, said day indicia corresponding to each of said predetermined areas to increase patient compliance with said complex dosing regimen by indicating which day the dosage units are to be administered; administering said nonprescription therapeutic substance and said prescription therapeutic substance together from said blister pack to an animal when indicated by said day indicia; wherein the complex dosing regimen requires simultaneous administration of said first and second biologically-active substances; said first biologically-active substance being storage-incompatible with said second biologically-active substance; and wherein said first recess and said second recess provide shelf stability by independently isolating in close proximity said first dosage unit and said second dosage unit to prevent interaction between the first and second biologically-active substances while facilitating simultaneous administration of said substances.
An alternative embodiment of the present invention is a method of increasing patient compliance with prescription therapeutic substances, which comprises providing a blister pack having at least one row of a plurality of predetermined areas; providing a first dosage unit containing a nonprescription substance in a recess in one predetermined area; providing a second dosage unit containing a prescription therapeutic substance in a recess in said blister pack such that said second dosage unit is located adjacent to said first dosage unit; providing indicia on said blister pack corresponding to said first and second dosage units; and administering said prescription therapeutic substance and said nonprescription substance together from said blister pack to an animal at the time indicated by said indicia.
A further embodiment of the present invention is a method for increasing patient compliance with a daily therapeutic regimen, which comprises providing a blister pack having at least one row of a plurality of predetermined areas; providing a first dosage unit containing a prescription therapeutic substance in a recess in one predetermined area; providing a second dosage unit containing a nonprescription therapeutic substance in a recess in said blister pack such that said second dosage unit is located adjacent to said first dosage unit; providing indicia on said blister pack corresponding to said first and second dosage units; and administering said nonprescription therapeutic substance and said prescription therapeutic substance together from said blister pack to an animal at the time indicated by said indicia.
Additional features and advantages of the present invention are described in, and will be apparent from, the detailed description of the presently preferred embodiments.